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Academic Medicine:
doi: 10.1097/ACM.0b013e3181acfbcd
Informed Consent

A Physician-Directed Intervention: Teaching and Measuring Better Informed Consent

Yap, Tsiao Yi MD; Yamokoski, Amy MA; Noll, Robert PhD; Drotar, Dennis PhD; Zyzanski, Steve PhD; Kodish, Eric D. MD; on behalf of the Multi-site Intervention Study to Improve Consent Research Team

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Author Information

Dr. Yap is a third-year pediatric hematology oncology fellow, Children’s Hospital Cleveland Clinic, Cleveland, Ohio.

Ms. Yamokoski is project manager, Multi-site Intervention Study to Improve Consent, Cleveland Clinic, Cleveland, Ohio.

Dr. Noll is director, Division of Developmental and Behavioral Pediatrics, and assistant medical director for behavioral health, Children’s Hospital of Pittsburgh, Pittsburgh, Pennsylvania.

Dr. Drotar is professor, Division of Behavioral Medicine and Clinical Psychology, and director, Center of Adherence and Self Management, Cincinnati Children’s Hospital, Cincinnati, Ohio.

Dr. Zyzanski is professor, Department of Family Medicine, Case Western Reserve University School of Medicine, Cleveland, Ohio.

Dr. Kodish is F.J. O’Neill Professor and Chair, Department of Bioethics, Cleveland Clinic, Cleveland, Ohio.

Correspondence should be addressed to Dr. Kodish, Department of Bioethics, Cleveland Clinic, 9500 Euclid Avenue JJ60, Cleveland, Ohio 44195; e-mail: (kodishe@ccf.org).

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Abstract

Purpose: To improve physician communication with parents using a physician-directed intervention (PDI), emphasizing a sequenced approach to the informed consent conference (ICC) for childhood leukemia clinical trials in which physicians discuss diagnosis, prognosis, and treatment prior to the offer of a clinical trial.

Method: Physicians and fellows at the Children’s Hospital of Philadelphia and Children’s National Medical Center were recruited to participate in Informed Consent Seminars and subsequent half-day booster sessions. Training was followed by a multisite study of informed consent communication. Real-life ICCs were observed and audiotaped, and parents were interviewed after the ICC to ascertain their understanding. Data from the ICC and interview were then coded and analyzed. Trained physician performances were compared with untrained physicians (controls) at two other research sites. Data were collected from 2003 to 2007 at PDI sites and control sites for comparison.

Results: A total of 102 cases were included for initial analyses, with 60 cases from the PDI sites and 42 control cases. Fifty-nine cases were included in the final analysis. Findings revealed that trained physicians followed the sequenced approach more often when compared with controls. Similarly, physicians at the PDI sites tended to elicit parental questions and understanding in an open-ended way and clarify parents’ questions more frequently than physicians at the control sites.

Conclusions: Academic physicians who are involved in the current transformation of clinical research should be trained to conduct effective ICCs. The “see one, do one, teach one” approach is no longer adequate for informed consent.

Treatment of childhood cancer is often cited as one of the “miracles” of modern medicine, and there has indeed been much improvement in the survival of children diagnosed with cancer during the past 20 years. The Surveillance Epidemiology and End Results Cancer Statistics Review reported five-year survival rates of 78.6% in the period from 1995 to 2001, compared with 55.9% from 1974 to 1976.1 This improvement of survival rates has been widely attributed to clinical research, primarily conducted with children diagnosed with leukemia—the most common childhood malignancy. A remarkable 90% of children diagnosed with cancer in this country are treated on randomized clinical trials (RCTs).2

In contrast to clinical research that takes place in the adult setting, most of the decisions for participation in an RCT for children are made by their parents or legal guardians. In our previous research, we examined communication between physicians and parents of children newly diagnosed with leukemia within the framework of the informed consent conference (ICC) by observing communication during the ICC and interviewing parents afterward.3 This work showed that physicians failed to effectively convey several critical concepts of informed consent in this challenging context. For example, the concepts of free choice about trial participation and randomization were verbally explained 89% and 83% of the time, respectively. However, only 67% of parents understood the concept of choice, and only 49% understood randomization.3,4 This is an important finding because it reflects a serious shortcoming in effective communication about research participation. Disclosure alone does not constitute effective communication.5 Although disclosure is necessary, it is not sufficient, and it must therefore be linked with understanding.

Our previous study culminated in the formation of a parent advisory group from parents who had been interviewed in our last study and who then took part in parent focus groups. Parents within the focus groups nominated peers to represent them at the parent advisory group meetings. Together with the research team, we invited 10 parents of children who had leukemia to interpret our data on informed consent and to propose a sequenced model to improve parental understanding and interactivity during the ICC.6 The sequenced approach emphasizes the importance of having multiple informed consent meetings (or at least pacing information disclosure) based on parental comprehension as illustrated in Figure 1. This model formed the conceptual basis of the physician-directed intervention (PDI) we report in this paper.

Figure 1
Figure 1
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The Parent Advisory Group on Informed Consent (PAGIC) model is a sequenced approach to informed consent developed in collaboration with parents of children with leukemia (Figure 1).6 We learned through the advisory group that parents are often compelled (or feel compelled) immediately following their child’s distressing diagnosis to make important decisions regarding trial participation. Most of the parents indicated a desire for more time to make a decision about RCT participation, echoing results of many other trials on parental perspectives regarding the informed consent process.7–9 Moreover, parents in PAGIC suggested strict adherence to a sequence that requires physicians to explain the disease prior to discussion of best available current treatment, and then requires that they offer RCT participation only after they’ve explained the disease and discussed best available treatment (Figure 1).

A review of the literature on ways to improve informed consent for research participation reveals that many strategies focus on improving parental/patient/participant understanding of informed consent, but few have attempted to improve physician delivery of information during an ICC. Among the few studies, most do not show any improvement in parental/patient understanding of informed consent despite attempts to train physicians to more effectively deliver information.10–13 Our previous research suggests that parental lack of understanding is not a result of lack of information. In fact, information overload and lack of organization during the ICC were key problems identified by parents.4 In this study, we present a physician-directed approach to improving physician communication during the informed consent process.

Results presented in this report are a component of the Multisite Intervention Study to Improve Consent (MUISIC), a large clinical trial examining the efficacy of several interventions designed to improve parental understanding of and active participation in the informed consent process for children diagnosed with acute leukemia. One approach embraces the principles of anticipatory guidance to prepare parents prior to the ICC; it is reported elsewhere.14 A second approach emphasizes training physicians prior to ICC. In this report, we describe the method and measurement of results from the PDI arm of the MUISIC study.

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Method

Training methods and contents

Coinvestigators at Children’s Hospital of Philadelphia, Pennsylvania and Children’s National Medical Center, Washington, DC identified physicians and fellows who treat pediatric leukemia patients at their respective institutions. Subsequently, the site coinvestigators approached these physicians to determine the best available dates for the training seminars. Once the dates of the seminars were determined, we sent out letters of invitation and a consent document to potential participating physicians. These physicians (Table 1) were recruited to participate in a communication training program called “Informed Consent Seminars” aimed at teaching methods to improve informed consent. The principal investigator of this study (E.D.K.), who is an ethicist and pediatric oncologist, and two coinvestigators (D.D., R.N.), who are behavioral scientists, conducted the training seminars at both sites. Research staff and parents of children with leukemia who were PAGIC members assisted the aforementioned seminar leaders.

Table 1
Table 1
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We conducted daylong seminars at both PDI sites, focusing on didactic teaching based on the PAGIC model.6 Power Point presentations illustrated the PAGIC model to participating physicians. We also provided physicians with data obtained from the Project on Informed Consent (PIC),4 emphasizing the poor understanding of randomization and choice of trial participation amongst parents of children with newly diagnosed leukemia. As seminar leaders, we stressed the importance of adherence to the sequenced approach to informed consent and the necessity of conducting at least two separate meetings, gauging parental understanding both cognitively and emotionally before moving onto the next component of the PAGIC model. During the seminars, we played audiotaped ICCs from the PIC4 to highlight and demonstrate examples of effective versus problematic communication techniques. At the ends of the seminars, attendees were equipped with a laminated PAGIC model pocket card, a copy of the PowerPoint slides, and a copy of the article “The Day One Talk” by Jennifer W. Mack and Holcombe E. Grier [J Clin Oncol. 2004;22:563-566].

We reinforced the major points of these seminars through half-day booster sessions during the course of data collection. At the Children’s National Medical Center PDI site, 14 physicians attended Informed Consent Seminars from February 2004 to July 2005. Two of the 14 attended a booster session in September 2004, and 5 attended a booster session in July 2005. At the Children’s Hospital of Philadelphia PDI site, 29 physicians attended the seminars from March 2004 to September 2005. Of these 29, 6 attended a booster session in October 2004, and 7 attended a booster session in September 2005. In addition, we used audiotaped ICC examples collected from PIC as practice cases. We presented three 40-minute cases during each booster session, prompting physicians to identify the positive or negative aspects of these taped ICCs. The attendees were then divided into groups of two and given the opportunity to role-play as physicians and parents with simulated cases. They were equipped with a Clinician ICC Checklist, a self-evaluation tool for clinicians during these role-play sessions to remind themselves of the important points discussed during the seminars. We kept an attendance record for each seminar so that we could exclude those ICCs featuring clinicians who did not attend at least one full training session prior to conducting the ICC from our analyses.

During the seminars, we taught clinicians to take cues from parents about how much information they are emotionally able to accept, and how much they would like to hear at the particular moment. Likewise, we encouraged clinicians to plan each ICC so that parents are given as much time as possible to make decisions about RCT. Metaphors are valuable tools of communication when trying to clarify the concept of randomization. We strongly encouraged physicians to use metaphors like “flip of a coin,” “picking a number out of the hat,” “a roll of the dice,” and “luck of the draw,” and to avoid misleading descriptions like “a computer decides” or “chosen by centralized group/national registry.” Seminar leaders trained physicians to assess literacy of the parents during the ICC by creating a shame-free environment and providing ample opportunity for parents to share their learning preferences. For example, we taught physicians that they should say to parents, “Tell me about how you like to learn best. Do you prefer to have discussions? Read from books or paper, or have others read to you?” These kinds of questions open the door for parents to subtly express any limited reading or writing abilities to their clinician.

The PAGIC model depends on teaching physicians that effective informed consent requires the delivery of three distinct components communicated during at least two separate meetings (Figure 1). During the first ICC, we taught physicians to discuss the patient’s diagnosis and review prognostic characteristics of leukemia. Other suggested topics of discussion during the first ICC meeting include the definition of leukemia, the subjects of remission and relapse, discussing patient’s test results, and psychological/existential aspects of the impact of this diagnosis (i.e., “Why my child?” and “Is this my fault?”). In one element of the seminar, we encouraged physicians to prompt for parental questions in an open-ended way. Once parents have demonstrated a good understanding of leukemia, we advised physicians to assess parental receptivity to further information. If parents are ready for more discussion, we advised physicians to move on to talk about leukemia treatment, including the general phases of therapy and goals of each phase, an outline of current best available therapy, and length of therapy and its side effects. Once parents demonstrate adequate understanding of these issues, seminar leaders taught physicians to proceed to introduce the idea of an RCT—ideally in a second ICC meeting. We advised physicians to open the second meeting with a general review of the main topics discussed during their first meeting with the parents, and then begin to discuss the rationale for the RCT, stressing that the goal of research is to improve treatment for future children with leukemia. In addition, we trained clinicians to introduce the differences between current best therapy and RCT participation, the meaning of randomization, and the voluntary nature of RCT participation during the second meeting. Two key psychological and ethical precepts of the PDI were to help physicians communicate to parents (1) that the best interests of their child will always be more important than the goals of research if they participate in the RCT, and (2) that their child will not receive inferior care if they choose to decline the RCT. Only when parents showed understanding of the concept of RCT should they then be asked to make a decision about whether their child would participate in the trial.

During the seminars, we also trained physicians in communication techniques to improve their delivery of key concepts during an ICC. Techniques included providing an empowering environment for parents during meetings and personalizing each interaction. Examples of these techniques included showing interest in and respect for the parents’ opinions, using the patient’s name during an ICC, asking questions about the patient and patient’s family, and showing empathy toward the patient and the patient’s family. We stressed that physicians should try to simplify information to improve parents’ understanding and avoid the use of medical jargon. One of the main topics of discussion during these seminars was the approach to using more accurate terminologies to describe “off study” therapy. To avoid biased interpretation of treatment alternatives, we encouraged physicians to refer to “off study” therapy as “current” treatment, which is a more neutral term than “standard” or “basic” treatment. As a suggestion to stimulate interchange and increase understanding, we encouraged physicians to go through the consent document page by page with parents during the ICC or to suggest that parents read the consent document during the ICC.

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Study recruitment and procedures

Prior to conducting this study, we trained research associates (RAs) to establish consistency in research methods across sites. All RAs attended initial training and orientation in Cleveland, Ohio at the beginning of the study. We taught RAs observation and interviewing techniques. In addition, each of them coded sample cases and received feedback from the project director prior to their “first” case. We conducted our research at Children’s Hospital of Philadelphia, Philadelphia, Pennsylvania (PDI site); Children’s National Medical Center, Washington, DC (PDI site); Children’s Healthcare of Atlanta at Scottish Rite, Atlanta, Georgia (control site); and Oakland Children’s Hospital in Oakland, California (control site). The study was approved by the IRBs at each of the four individual sites listed above.

Data collection began on March 4, 2003 and ended on October 12, 2007. Informed consent for the MUISIC study was obtained from parents after their child was diagnosed with acute leukemia. We invited eligible parents to participate in a study of communication that included observation and taping of the ICC and follow-up interviewing, but parents were not explicitly informed that their physician may have been present at an Informed Consent Seminar training session described above. The ICCs were then observed and audiotaped by trained RAs. RAs interviewed parents within 72 hours after the completion of the ICCs.

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Analysis and statistical considerations

The ICCs were initially coded by the site RA using the Observer Checklist, a tool designed to examine behaviors specific to discussions related to cancer.15 The Observer Checklist is divided into sections documenting information about leukemia and its treatment separately from information about the RCT. All events were coded as occurring or not occurring, and the checklist contents were coded as being initiated by the clinician, patient, or patient’s family. The checklist also includes a descriptive contextual section. We trained RAs to refer to the Observer Checklist Rulebook each time they coded a new ICC. Items were coded based on the first occurrence of a behavior and not subsequent ones. After the site RA’s initial coding, two other project members at the Cleveland site coded every ICC from each institution. The cases were then reconciled using a preestablished coding rulebook. Final codes were entered into the project database for analyses. We then assessed ICCs to determine physician adherence to the PAGIC model.

After the ICC, RAs interviewed parents to determine (1) their understanding of their voluntary choice to participate in the clinical trial, and (2) their understanding of what randomization means for their child. We used SPSS statistical software version 11.0 for analysis (SPSS, Chicago, Illinois).

We compared the data from PDI site cases with cases at the control sites where no intervention was conducted. Because case attrition led to a limited sample size (Figure 2), this reduced sample size has 80% power to detect only a large percentage difference (>35%) between study groups. Therefore, we chose to interpret as clinically meaningful both associations significant at P < .05 as well as associations exhibiting a medium (20% difference) or larger effect size.16 We analyzed categorical variables by means of exact chi-square statistics and continuous variables by t test for independent groups.

Figure 2
Figure 2
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Results

Parents of 102 newly diagnosed children agreed to participate, 60 at the PDI sites and 42 at control sites. We excluded 14 cases in which the ICCs were performed by physicians at the PDI sites who did not attend any seminars and, therefore, were not trained with this intervention. As part of our study exclusion criteria, we excluded cases when RAs were not able to attend all ICCs and when patients were not offered a clinical trial. This report therefore includes analysis on a total of 59 cases, 33 from physician directed intervention sites and 26 from control sites (Figure 2).

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Demographic characteristics

Parent participants included 45 females and 14 males, with mean ages of 36.1 years at the PDI sites and 34.2 years at the control sites. The children, 30 girls and 29 boys, had a mean age of 5.9 years at the PDI sites and 7.0 years at the control sites. Ethnic minorities represented 45.5% of cases at the PDI sites and 38.5% at the control sites. A low index of social position17 was noted in 30% of cases at the PDI sites and 54% at the control sites. (Table 2) A total of 48 children were diagnosed with acute lymphoblastic leukemia and 10 with acute myelogenous leukemia. The acute lymphoblastic leukemia patients were stratified into different risk groups according to their prognostic characteristics and treated according to specific risk group protocols.

Table 2
Table 2
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ICC features and physician adherence to the PAGIC model

The mean conference length for PDI cases was 93 minutes (SD = 34.6, range 33-191) compared with 79 minutes (SD = 28.1, range 29-167) in control cases (P ≤ .09). A total of 43 physicians completed training from both PDI sites combined. One of the aims of our study was to teach physicians to engage parents in the informed consent process. We strongly advised physicians to invite parents to ask questions and elicit understanding from parents in an open-ended way. In addition, we also encouraged physicians to ask for clarification of parent questions or comments during the ICCs. Our analysis showed that physicians at the PDI sites tended to elicit parental questions and understanding in an open-ended way more frequently than physicians at the control sites (P < .03). At the same time, clinicians at the PDI sites were better at clarifying parents’ questions or comments (P < .09) when compared with physicians at the control sites (Table 3).

Table 3
Table 3
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Remarkably, the PDI group showed improved adherence to all nine of the PAGIC criteria we examined compared with the control group. We found that, when compared with controls, physicians in the PDI group were more likely to discuss diagnosis (31 cases or 94% versus 20 cases or 77%; P ≤ .058), explain the definition of leukemia (26 cases or 79% versus 8 cases or 31%; P ≤ .001), discuss prognosis of illness (29 cases or 88% versus 15 cases or 58%; P ≤ .008), discuss prognosis characteristics of leukemia (26 cases or 79% versus 11 cases or 42%; P ≤ .004), explain the patient’s test results in regard to their illness (24 cases or 73% versus 5 cases or 19%; P ≤ .000), and define the meaning of remission/relapse (25 cases or 76% versus 9 cases or 35%; P ≤ .001) before talking to parents about RCTs. PDI group physicians consistently outlined a current “off study” treatment plan (27 cases or 82% versus 16 cases or 62%, P ≤ .082), specified the length of current “off study” therapy (27 cases or 82% versus 15 cases or 58%, P < .042), and described side effects of therapy (28 cases or 85% versus 10 cases or 39%, P < .000) prior to any discussion about RCT (Table 4).

Table 4
Table 4
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Eighty-five percent of parents (28 cases) at the PDI sites were able to understand their voluntary choice about trial participation, whereas only 62% of parents (16 cases) at the control sites were able to do so (P = .04). Interestingly, there was not a significant difference in parental understanding of randomization when these two groups were compared (20/26 cases or 77% versus 14/18 cases or 78%). The total number of cases analyzed for parental understanding of randomization was 44 instead of 59, because we excluded subjects who were not offered a randomized clinical trial.

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Discussion

Informed consent is the backbone of sound ethical research. Many previous studies have found that parents often have poor understanding of pediatric research participation.9,18,19 In addition, clinicians often face the difficulty of having to obtain consent within hours of diagnosis, adding much pressure to already stressed parents.19 To make matters worse, most physicians have no formal training in how to conduct an ICC.12,20 Our study attempted to change clinicians’ approach to ICCs through didactic teaching seminars and hands-on learning from cases by reviewing positive and negative models of informed consent style and role modeling with ICC cases. We developed the foundations of these teaching session components from our prior study with the help of participating parents of children diagnosed with leukemia as described above.6 This study showed that physicians who underwent training adhered to the PAGIC sequence model consistently when compared with clinicians at the control sites. In fact, we noted a statistically significant difference between PDI and control cases in virtually every ICC criteria we coded, suggesting a powerful effect of this intervention on physician communication behavior.

It is important to stress that good communication plays a critical role in the informed consent process.3,11,21,22 We used our training modules to highlight some contributing factors and techniques to improve communication between physicians and parents. These include providing an emotionally supportive environment for parents and patients, simplifying information using pictures or diagrams, using appropriate analogies or metaphors, and limiting medical jargon to facilitate parental understanding. We also encouraged stimulation of reciprocal information exchange between the provider and the parents. We trained physicians to prompt for communication by inviting parents to ask questions and eliciting their understanding in an open-ended way. These physicians were also trained to clarify parental questions or comments. Physicians who were trained performed better than their untrained counterparts in these ways.

The ultimate goal of improved physician performance during the ICC is enhanced parental understanding. The specific understanding outcomes we analyzed in this study were choice and randomization. During the parent interviews after the ICCs, we asked parents questions to determine whether they understood randomization and to assess their understanding that they had a choice between current treatment and RCT participation. We found that 85% of parents in the PDI sites were able to appreciate choice as compared with only 62% in the control arm (P = .04). There were no significant differences when it came to understanding randomization between the two arms. Of note, the sample size for analysis of the understanding randomization variable was limited to 44 cases because the remaining 15 cases were offered nonrandomized clinical trials. By contrast, our previous study with a larger sample size reported that only 50% (68 cases out of a total of 138 cases from the PIC study) of parents understood randomization when no intervention was used.4 The lack of effect in the PDI group for understanding of randomization compared with the control group may be a function of the control group’s small sample size.

There are several limitations to be considered in interpreting these data. First, the study design could be criticized because allocation of the intervention was not by case but rather by study site. This decision was made to ensure consistency within sites and to prevent cross-contamination among PDI participants. Another potential limitation of our study is selection bias of physicians within the PDI sites. Clinicians who participated and attended the training seminars may have been more interested in changing their behavior and approach to conducting ICCs. Because we did not audiotape ICCs conducted by these physicians prior to the Informed Consent Seminars, it is difficult to assess the improvement in ICC performance among physicians at the PDI sites. Finally, each of our research sites was a large urban children’s hospital, and these findings may not apply in other contexts.

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Conclusions

Interventions to improve the informed consent process continue to be a challenge. In our study, the audiotaped ICCs were analyzed quantitatively; future qualitative analysis may provide more information regarding communication between physicians and parents during the informed consent process. Studies examining the strengths and weaknesses of these interventions can serve as a basis for improving the design and methods of future interventions to further develop the informed consent process. Although our study was in the context of childhood cancer, such studies should also be considered in other clinical and research settings. Academic physicians who are involved in the current transformation of clinical research should be trained to conduct effective ICCs.23 The “see one, do one, teach one” approach is no longer adequate for informed consent.

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Acknowledgments

The authors would like to thank the MUISIC Research Team: Anne Angiolillo, MD (Co-Investigator), Children’s National Medical Center, Washington, DC; Michelle Eder, PhD, Center for Health Research, Kaiser Permanente, Portland, Oregon; James Feusner, MD (Co-Investigator), Children’s Hospital of Oakland, Oakland, California; Anita Khayat, PhD, Children’s Oncology Group, Arcadia, California; Glen Lew, MD (Co-Investigator), Children’s Healthcare of Atlanta, Atlanta, Georgia; Anne Reilly, MD (Co-Investigator), The Children’s Hospital of Philadelphia, Philadelphia, Pennsylvania; Kathy Ruccione, RN, MPH (Co-Investigator), Children’s Hospital Los Angeles, Los Angeles, California. They would also like to thank all other research staff, physicians, nurse-educators, and families who participated in this research. Finally, the authors would like to acknowledge Ariane Mitchum for her assistance with coding and Sabahat Hizlan for her assistance with data analysis and reporting.

This work was supported by a grant from the National Cancer Institute (R01 CA 083267).

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